Kornimate/medical-research-clean huggingface dataset:
long term results after hip arthroscopy

Conditions: Femoro Acetabular Impingement

Summary: a common cause of hip joint pain in the young and active population is femoroacetabular impingement (fai) syndrome. if fai is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (oa). hip arthroscopy is the first choice of operative treatment for fai. while hip arthroscopy improves the patient reported outcome measures (proms), the influence of this treatment on the contribution to the development of osteoarthritis after fai is to the best of our knowledge still unknown.


Eligibility criteria:
in order to be eligible to participate in this study, a subject must meet all of the following criteria: inclusion criteria: * patient who participated in the cohort study; * at least 5 years of follow up; * patient is able to understand the meaning of the study and is willing to sign the informed consent form. a potential subject who meets any of the following criteria will be excluded from participation in this study: exclusion criteria: * patient who has had hip arthroscopy of both sides; * patient is unable or unwilling to sing informed consent
bivalirudin in stable ischemic heart disease patients undergoing pci

Conditions: Coronary Disease

Summary: prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary pci. the investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the pci recommended dose for 4 hours would prevent myocardial damage.

bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (pci) for coronary heart disease. prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary pci . however, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. the investigators examined the effects of prolonged drug infusion after elective pci. the investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the pci recommended dose for 4 hours would prevent myocardial damage.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years with stable ischemic heart disease in whom pci was required. exclusion criteria: * cardiogenic shock; * thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; * active or recent major bleeding or bleeding predisposition; * major surgery within 1 month; * clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; * blood pressure higher than 180/110 mm hg; * known hemoglobin less than 10 g/dl, platelet count less than 100 × 109/l, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 ml/min; * history of heparin-induced thrombocytopenia; * allergy to any of the study drugs or devices; * pregnancy or lactation; * any condition making pci unsuitable or that might interfere with study adherence; and * patient unwilling or unable to provide written informed consent.

Keywords: bivalirudin myocardial injure
clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice specimen extraction

Conditions: Rectal Neoplasms; Robotic Surgery; Natural Orifice Specimen Extraction Surgery

Summary: robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. however, it's safety and feasibility remain undiscussed and controversial. this study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question.

robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. however, it's safety and feasibility remain undiscussed and controversial. this study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question. from january 2015 to november 2016, a consecutive wave of 49 patients underwent robotic rectal cancer resection with natural orifice extraction and 49 matched patients underwent conventional robotic assisted rectal cancer resection were systematically analyzed in this study.

Eligibility criteria:
inclusion criteria: 1. t stage 1-3; 2. aged between 18 to 75; 3. the tumor margin is at least 4 cm from the anus; 4. body mass index ≤30kg/m2; 5. no distant metastases； (6）tumor size≤5cm. exclusion criteria: 1. emergency surgery for intestinal obstruction or massive bleeding; 2. history of abdominal or pelvic surgery.
comparison of pk after administration of hcp1201 and co-administration of metformin sr 750mg and rosuvastatin 10mg

Conditions: Diabetes Mellitus

Summary: to compare the pharmacokinetic characteristics between hcp1201 tablet 750/10 mg and co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.

an open-label, randomized, single-dose crossover study to compare the pharmacokinetics after the administration of hcp1201 tablet 750/10 mg and coadministration of metformin sr 750 mg and rosuvastatin 10 mg in healthy volunteers

Eligibility criteria:
inclusion criteria: * healthy male volunteer, age 20\~55 years * the result of body mass index(bmi) is not less than 19 kg/m2 , no more than 27 kg/m2 * subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study * history of relevant drug allergies or clinically significant hypersensitivity reaction.
the atlast long-term study

Conditions: Obstructive Sleep Apnea (OSA)

Summary: the study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the attune sleep apnea system for the treatment of obstructive sleep apnea (osa). the objective of the study is to monitor long-term use of the attune sleep apnea system.


Eligibility criteria:
inclusion criteria: * subject participated in the atlast study, and completed the 28-day take-home period * subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form. * the study physician and investigator believe that study participation is appropriate for the subject. * subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower). exclusion criteria: * female subjects who are pregnant or intend to become pregnant during the study period. * poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed. * oral cavity infection or any other oral or dental condition or problem that would limit subject use of the attune sleep apnea system * history of any osa surgical treatment
neurotoxin and physical therapy

Conditions: Cervical Dystonia

Summary: this study aims to compare botox injections without physical therapy sessions to botox injections combined with physical therapy sessions for treatment of cervical dystonia. it is expected that botox combined with physical therapy will improve cervical dystonia symptoms and quality of life more than botox alone. it is also expected that botox combined with physical therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than botox alone at 4-5 weeks, and remain improved at 12 weeks, after botox injection.

the study will recruit primary cervical dystonia patients (age 18-80) who are stable on allergan botulinum toxin type a (botox). patients will be randomized to receive their typical botox injection alone, or with physical therapy. at baseline, disease characteristics (as measured by the toronto western spasmodic torticollis rating scale, or twstrs, and the clinical global impression of severity, or cgis) will be measured, along with quality of life (from the short health 36 survey form 36, or sf-36). one subscale of the twstrs will be videotaped to be later evaluated by blinded movement disorder specialists. a pain scale will also be completed and range of head motion will be measured using a device similar to a protractor (called a goniometer). an individualized botox injection will be administered, as well as transcranial magnetic stimulation (tms) to measure neuroplasticity, or the ability of the brain to make new connections. if randomized to receive physical therapy, participants will also receive instructions to perform physical therapy exercises five times per week by a physical therapist who specializes in movement disorders. the investigator will call weekly to check how the participant is doing with the exercise program. the same procedures outlined above will also be performed at 5 weeks past baseline, and at 12 weeks (except for the botox injection, which will only be given at baseline and 12 weeks).

Eligibility criteria:
inclusion criteria: * aged 18-80 with a diagnosis of cervical dystonia, which will be confirmed by a movement disorders specialist * positive response to at least two prior treatments with botox as indicated by an improvement in clinical global improvement scale. * received last dose of botox a minimum of 12 weeks prior to baseline visit. exclusion criteria: * any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy) * any secondary, fixed, post-traumatic, or psychogenic dystonia

Keywords: cervical dystonia botox
combination chemotherapy with or without radiation therapy in treating patients with stage iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. radiation therapy uses high-energy x-rays to damage tumor cells. it is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage iiia non-small cell lung cancer. purpose: randomized phase iii trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage iiia non-small cell lung cancer that has been surgically removed.

objectives: i. compare the overall survival of surgically resected patients with limited stage iiia non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy. ii. compare failure free survival of these patients. iii. describe the patterns of local and distant recurrence in these patients. iv. determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients. outline: this is a randomized, multicenter study. four to eight weeks after surgery, all patients receive paclitaxel iv over 3 hours followed by carboplatin iv over 1-2 hours on days 1, 22, 43, and 64. following completion of four courses of chemotherapy, patients are randomized into one of two treatment arms.

Eligibility criteria:
disease characteristics: histologically confirmed stage iiia non-small cell lung cancer that has been completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video assisted resection is acceptable) no known residual disease present involvement in n2 nodes must have been determined only at the time of surgical exploration or by postoperative pathologic diagnosis all grossly involved nodes must be removed at surgery no positive mediastinoscopy (if lymph nodes on ct scan are greater than 1.5 cm in diameter, mediastinoscopy is required) patient characteristics: age: 18 and over performance status: zubrod 0-1 life expectancy: not specified hematopoietic: granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 1.5 mg/dl sgot no greater than upper limit of normal renal: creatinine clearance at least 20 ml/min other: not pregnant or nursing prior concurrent therapy: biologic therapy: no concurrent growth factors chemotherapy: no prior chemotherapy for non-small cell lung cancer no other concurrent chemotherapy endocrine therapy: no concurrent hormone therapy except: steroids for adrenal failure hormones for nondisease related conditions dexamethasone as an antiemetic radiation therapy: no prior radiotherapy for non-small cell lung cancer surgery: see disease characteristics

Keywords: stage iiia non-small cell lung cancer
bingo drug-eluting balloon in bifurcation

Conditions: Bifurcation Lesions; Drug Eluting Balloon

Summary: the purpose is to observe and evaluate the safety and efficacy of bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female ages 18-80 years old 2. patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction 3. patients with bifurcation lesions of coronary artery observed by angiography. 4. the main branch of the vessels are suitable for pci and stent therapy, and the side branch are intended to implement the kissing dilatation without considering dual stent implantation. 5. de novo bifurcation lesions and diameter stenosis are not less than70%; 6. referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm 7. residual stenosis are not more than 50% after predilatation; 8. patients who understand the purpose of this trial, voluntary and sign informed consent. exclusion criteria: 1. heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty 2. left main coronary artery lesions without protection or related bifurcation lesions 3. patients with severe heart failure symptoms (above nyha iii) or left ventricular ejection fraction (lvef) below 35% (ultrasound or left ventricular angiography) 4. impairment of the renal function preoperative: serum creatinine above 2.0mg/dl； 5. patients with hemorrhagic tendency, the history of active digestive ulcers, the history of subarachnoid hemorrhage cerebral hemorrhage, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy; 6. patients who are allergic to aspirin, ticagrelor, clopidogrel, ticlopidine, heparin, contrast agent and paclitaxel, and cannot 1-year tolerate dual antiplatelet therapy (aspirin + clopidogrel or ticagrelor) 7. patients whose expected lives are less than 1 year; 8. patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements. 9. in-stent restenosis lesions 10. patients who are enrolled in this trial and need stent therapy due to vascular laceration or severe stenosis, and those patients are calculated as fall off cases.

Keywords: bifurcation lesions drug eluting balloon paclitaxel drug coated balloon
pilot study of (61)cuatsm-pet imaging in cancer patients

Conditions: CNS Brain Metastases; Head and Neck Cancer; Lung Cancer; Prostate Cancer; Esophageal Cancer

Summary: hypoxia is a key factor in malignant progression of a neoplasm. it is our aim to explore the basis for quantitative in vivo tumor imaging by cu-61 diacetyl-bis(n4-methylthiosemicarbazone)pet imaging as a surrogate of tissue hypoxia. we hypothesize that the hypoxia levels are predictive of the tumor response to therapy. patients will have 2 cu-atsm pet scans done and the goal is to show spatially stable tracer distributions that correlate with tumor hypoxia. this study will serve as a pilot study for a po1 submission


Eligibility criteria:
inclusion criteria: * able to tolerated a pet/ct scan * age 18 or older * patient being considered for xrt for treatment of their cancer * able to provide written informed consent exclusion criteria: * severe claustrophobia or inability to tolerate the pet scan * pregnant or breastfeeding women * patients that need supplemental oxygen * patients enrolled in experimental treatments
brain activity during birth for prediction of newborns at risk for brain injury

Conditions: Encephalopathy; Asphyxia Newborns

Summary: the purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.

there is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes. this study is designed to record eeg during birth transition through the first 10 minutes of life.

Eligibility criteria:
inclusion criteria: term infants * signed informed consent exclusion criteria: * known congenital anomalies

Keywords: perinatal depression
assessment of drug-drug interactions between feminizing hormone therapy and emtricitabine/tenofovir alafenamide concomitantly for pre-exposure prophylaxis among transgender women

Conditions: Drug Interaction

Summary: recent studies have showed that there were significant drug-drug interactions (ddi) from feminizing hormone therapy (fht) towards emtricitabine/tenofovir disoproxil fumarate (f/tdf)-based pre-exposure prophylaxis (prep) among transgender women (tgw). new strategies for prep among tgw who use fht are urgently needed. because tenofovir alafenamide (taf) can achieve higher intracellular tfv-dp levels with lower tenofovir plasma concentrations, it is promising that both plasma tfv and intracellular tfv-dp levels might not be significantly affected by fht. the current study aims to determine the pharmacokinetics ddi between fht and f/taf-based prep among tgw.

two full pharmacokinetic (pk) measurements will be performed. samples collected will include: plasma for estradiol (e2), emtricitabine (ftc), tenofovir (tfv), and tenofovir alafenamide (taf) measurement; and peripheral blood mononuclear cells (pbmc) for emtricitabine-triphosphate (ftc-tp) and tenofovir-diphosphate (tfv-dp) intracellular quantification.

Eligibility criteria:
inclusion criteria: 1. thai nationality 2. age 18-40 years old 3. transgender women 4. hiv-negative 5. body mass index 18.5-24.9 kg/m2 6. calculated creatinine clearance (crcl) ≥60 ml/min, as estimated by the cockcroft-gault equation 7. alanine aminotransferase (alt) ≤2.5 x uln 8. signed the informed consent form exclusion criteria: 1. known history of allergy to hormonal component to be used in the study 2. male-to-female transgender who underwent orchiectomy 3. use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days 4. use of injectable fht in the past 3 months 5. evidence of current hepatitis b virus infection (hbv) - i.e. hepatitis b surface antigen (hbsag) positive 6. evidence of current hepatitis c virus infection (hcv) - i.e. hcv antibody positive 7. current use of any of the following: * anticonvulsants: carbamazepine, felbamate, oxcarbazepine, phenytoin, phenobarbital, primidone or topiramate * herbs: gingko biloba, st john's wort or milk thistle * anti-infective agents: azole antifungals, macrolides, griseofulvin, protease inhibitors, rifampicin or rifabutin 8. participant-reported active rectal infection requiring treatment 9. history of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption 10. alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
a pilot study of pre- and post-operative use of somatuline depot.

Conditions: Acromegaly

Summary: if someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. this study has two phases. the first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. the drug administered is approved by the fda for long-term treatment of acromegaly. it is not routinely administered before surgery, and is therefore experimental as used in this way. all other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit. the second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. this phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. the drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. all other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit. the study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.


Eligibility criteria:
inclusion criteria: * age 18 - 75 * elevated serum insulin-like growth factor-1 (igf-1) level above age- and sex-based normal values and failure of growth hormone(gh) suppression to \< 1.0 ng/ml after a 75 gm oral glucose tolerance test (ogtt) american association of clinical endocrinolgists (aace) acromegaly clinical guidelines 2004 * visible pituitary adenoma (microadenoma or macroadenoma) on high quality pituitary mri without and with gadolinium * prior treatments for acromegaly with surgery, somatostatin analogs or pegvisomant are acceptable if these therapies have been discontinued for at least 3 months prior to study entry exclusion criteria: * age \ 75 years * acromegalic patients currently on a lanreotide or octreotide preparation or on pegvisomant * patients who have received prior radiotherapy or radiosurgery * patients with adenoma-related visual acuity or visual field deficit from optic nerve and/or chiasm compression or severe optic nerve/chiasm compression in the setting of normal visual fields and acuity * patients with pituitary apoplexy defined as recent tumor hemorrhage and/or infarction on mri with associated symptoms of new onset visual loss, diplopia and/or adrenal insufficiency

Keywords: excess growth hormone excess gh gigantism pituitary tumor pituitary adenoma growth hormone tumor gh secreting adenoma somatuline lanreotide